Registration Dossier
Registration Dossier
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EC number: 922-153-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989/12/12 - 1990/1/31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: In agreement with OECD test guideline 404. GLP
- Justification for type of information:
- The justification for read across is provided as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1989/12/12 - 1990/1/31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: In agreement with OECD test guideline 404. GLP
- Justification for type of information:
- The justification for read across is provided as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 1
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.83
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 2
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- ca. 0.67
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 0.33
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.17
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.94
- Irritant / corrosive response data:
- Topical application of MRD-89-524 elicited dermal responses in 4 out of 6 animals. At the 1-, 24-, and 72-hour observations two animals were noted with a well defined erythema and very slight edema. One animal was noted with well defined erythema and three animals were noted with very slight erythema at the 48-hour observation. At day 7, four animals were noted with very slight erythema.
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The average erythema score (24, 48, and 72 hours) was 0.94. The average edema score (24, 48, and 72 hours) was 0.06. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
- Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C10-C13, aromatics, >1% naphthalene, based on analogue read across.
In this study, 6 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of MRD-89-524 via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and on day 7 according to the Draize method of scoring. At the 1-, 24-, and 72-hour observations two animals were noted with a well defined erythema and very slight edema. One animal was noted with well defined erythema and three animals were noted with very slight erythema at the 48-hour observation. At day 7, four animals were noted with very slight erythema. The average erythema score (24, 48, and 72 hours) was 0.94. The average edema score (24, 48, and 72 hours) was 0.06. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrocarbons, C10-C13, aromatics, >1% naphthalene
- EC Number:
- 926-273-4
- Molecular formula:
- None available - not a single isomer - see remarks
- IUPAC Name:
- Hydrocarbons, C10-C13, aromatics, >1% naphthalene
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: Hazleton Research Products
Sex: Male (3), Female (3)
Age at study initiation: Approximately 12 weeks
Weight at study initiation: 2.00-3.00 kg
Housing: Individually
Diet (e.g. ad libitum): Agway Certified Diet R.C.A. Rabbit (pellets), restricted as per recommendation of supplier
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 22d
ENVIRONMENTAL CONDITIONS
Temperature (°F): 65 to 74
Humidity (%): 30-70%
Photoperiod (hrs dark / hrs light): 12/12
Monitored at least once a day
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Amount(s) applied (volume or weight): 0.5 ml
Concentration (if solution): neat - Duration of treatment / exposure:
- Test material was administered to the clipped backs as a single dose introduced under a gauze patch (secured with non-irritating tape) and held in contact with the skin by means of a semi-occlusive dressing for 4 hours. Residual test material was then removed.
- Observation period:
- 45 min, 24, 48, and 72h post application and once per day on Day 7
- Number of animals:
- Male (3), Female (3)
- Details on study design:
- SCORING SYSTEM: Draize scale for dermal irritation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 1
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.83
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 2
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- ca. 0.67
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 0.33
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.17
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.94
- Irritant / corrosive response data:
- Topical application of MRD-89-524 elicited dermal responses in 4 out of 6 animals. At the 1-, 24-, and 72-hour observations two animals were noted with a well defined erythema and very slight edema. One animal was noted with well defined erythema and three animals were noted with very slight erythema at the 48-hour observation. At day 7, four animals were noted with very slight erythema.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The average erythema score (24, 48, and 72 hours) was 0.94. The average edema score (24, 48, and 72 hours) was 0.06. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
- Executive summary:
In this study, 6 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of MRD-89-524 via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and on day 7 according to the Draize method of scoring. At the 1-, 24-, and 72-hour observations two animals were noted with a well defined erythema and very slight edema. One animal was noted with well defined erythema and three animals were noted with very slight erythema at the 48-hour observation. At day 7, four animals were noted with very slight erythema. The average erythema score (24, 48, and 72 hours) was 0.94. The average edema score (24, 48, and 72 hours) was 0.06. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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